The primary efficacy objective is to determine that the Guardian System reduces the composite of Cardiac or unexplained death, new Q-wave MI and time to door for a confirmed occlusive event at a medical facility >2 hours [ Time Frame: Due to Bayesian statistical analysis, the study data will be analyzed after subject enrollment reaches 600, 900, 1200, etc. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ICMJE (submitted: October 27, 2008)

The primary objective is efficacy. Determine if the Guardian System reduces the composite of Cardiac or unexplained death, new Q-wave MI and time to door at a medical facility >2 hours [ Time Frame: Due to Bayesian statistical analysis, the study data will be analyzed after subject enrollment reaches 900, 1200, 1500, etc. ] [ Designated as safety issue: No ]

- Reduction of the incidence of cardiac death or unexplained death during follow-up - Reduction of the incidence of "New" Q-wave myocardial infarction in one or more distributions during follow-up - Reduction of the time to door for confirmed STEMI [ Time Frame: Due to Bayesian statistical analysis, the study data will be analyzed after subject enrollment reaches 600, 900, 1200, etc ] [ Designated as safety issue: No ]

- Reduction of the incidence of cardiac death or unexplained death during follow-up - Reduction of the incidence of "New" Q-wave myocardial infarction in one or more distributions during follow-up - Reduction of the time to door for confirmed STEMI [ Time Frame: Due to Bayesian statistical analysis, the study data will be analyzed after subject enrollment reaches 900, 1200, 1500, etc ] [ Designated as safety issue: No ]

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

AngelMed for Early Recognition and Treatment of STEMI

Official Title ICMJE

AngelMed for Early Recognition and Treatment of STEMI

Brief Summary

A prospective, randomized multicenter study of subjects with a high-risk of having a myocardial infarction (MI) due to acute coronary syndrome or bypass surgery.

Detailed Description

There are over one million acute myocardial infarctions (AMI) each year in the United States with more than 400,000 of these resulting in death. Early identification of AMI, and prompt treatment has been shown to significantly improve clinical outcomes. Experimental and clinical studies have shown that most of the irreversible damage to the myocardium occurs during the first two hours after coronary occlusion. Milavetz et al. demonstrated that successful reperfusion therapy within two hours was associated with the greatest degree of myocardial salvage. According to Boersma, et al., restoration of flow, regardless of the method used, can abort infarction within the first 30 minutes after coronary occlusion, and the benefit of fibrinolytic therapy compared with placebo is considerably higher in patients treated within 2 hours after symptom onset than in those treated later.2 Further, evidence exists that expeditious restoration of flow in the obstructed infarct artery after the onset of symptoms in patients with the most severe type of MI, ST elevation MI (STEMI) is a key determinant of short and long-term outcomes regardless of whether reperfusion is accomplished by fibrinolysis or percutaneous coronary intervention (PCI). Therefore, the early arrival at the hospital for a reliable diagnosis and initiation of treatment is paramount to improve the outcomes of myocardial infarction. However, despite efforts at educating the public over the past decade, the mean time from AMI symptom onset to arrival at a hospital for treatment has remained, disappointingly, at 2.5-3.0 hours.

The largest proportion of the total pre-hospital delay is the interval between the onset of symptoms and the decision to seek medical treatment. Finnegan et al. described that the reasons for delay in seeking medical evaluation generally stem from patient misconceptions about symptom experience, expectations, and attribution. In many cases, patients expect the type of heart attack that they often see in movies or on television: the kind of crushing chest pain that drops a person to the ground. The reality is that many heart attacks are much "quieter," causing only mild chest pain or discomfort or other symptoms such as shortness of breath or diaphoresis.

If patients would take action during the first hour following symptom onset, many lives and significant cost could be saved. It is technically possible to monitor EKGs and detect an acute infarction, even if the patient is unaware that he or she is experiencing a heart attack. However, currently available systems have limitations in the home environment. Twelve lead EKG systems require a clinically trained individual to place them. Holter monitors suffer from limitations in the ability to detect ST deviation due to low compliance and are limited in practice to 24 to 72 hours of monitoring. Systems using surface leads are all subject to noise and other artifacts from patient movement and body orientation, particularly if the patient is ambulatory.

A potentially ideal solution is to implant a device that measures heart signals from inside the heart and will alert the patient when it detects electrogram characteristics set by the physician as worthy of medical evaluation.

There is no intervention in this study. The device is a diagnostic only.

Study Arm (s)

Experimental: Treatment

There is no intervention administered in the ALERTS Study. The study is testing whether or not a patient alarm from the Guardian System will bring them into the ER faster than symptoms only in the event of a heart attack.

The Treatment arm has alerting enabled in their device. The Control arm has alerting disabled in their device. Once a patient arrives at the ER, the standard of care triage process for MI is followed and that is outside of the ALERTS Study protocol.

Intervention: Device: Guardian System

Control

There is no intervention administered in the ALERTS Study. The study is testing whether or not a patient alarm from the Guardian System will bring them into the ER faster than symptoms only in the event of a heart attack.

The Treatment arm has alerting enabled in their device. The Control arm has alerting disabled in their device. Once a patient arrives at the ER, the standard of care triage process for MI is followed and that is outside of the ALERTS Study protocol.

There is known compromised tissue at the site of lead implantation in the apex of the right ventricle, e.g., prior infarct affecting the RV apex location.

A permanent pacemaker or ICD is already in place or the patient is indicated for ICD or pacemaker implantation based on the guidelines published by the American College of Cardiology as Class I and IIa recommendations. Class IIb recommendations are at the investigator's discretion.

Subject cannot feel the IMD vibration when placed on top of the skin on the left pectoral side of the chest.

Subject has any condition preventing the subcutaneous implantation of the Guardian System in a left pectoral pouch, such as: superior vena cava thrombosis, subcutaneous tissue deemed inappropriate for the procedure or prior central venous access via portacath, Hickman, Groshong, or similar placed in a left pectoral location or left side PICC line.

Subject has extremely heavy alcohol consumption (participates in binge drinking that leads to alcohol intoxication) or has history of alcohol or illicit drug abuse within past 5 years.

Subject has had a hemorrhagic stroke or transient ischemic attack (TIA) in the past 6 months.

Subject has other severe diseases, such as cancer or refractory congestive heart failure, associated with limitation of life expectancy (less than 1 year), which may lead to inadequate compliance to the protocol or confusing data interpretation.

Subject has clinical conditions such as heart diseases, difficult-to-control blood pressure, difficult-to-control insulin-dependent diabetes or serious prior infections attributed to the diabetes, or others that, at the investigator's discretion, could seriously affect the subject's current clinical condition during study procedures.

Subject has previous participation in the DETECT Study, current participation or previous participation in another drug or device study in the past 30 days that conflicts with this study as determined by the study sponsor.

Subject has experienced gastro-intestinal hemorrhage in the past 6 months.

Subject has any situation in which the use of aspirin is contraindicated for at least 6 months.

Subject has epilepsy.

Subject has known severe allergies, e.g., peanut, bee sting, etc.

Gender

Both

Ages

21 Years and older (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ICMJE

NCT00781118

Other Study ID Numbers ICMJE

ALERTS Study

Has Data Monitoring Committee

Yes

Plan to Share Data

Yes

IPD Description

When we have completed review with the FDA, the IPD will will be made available.